FDA Warning – Time to get personal

In a move guaranteed to send shock waves around the industry, FDA lawyers just announced that CEOs of pharmaceutical companies could face prosecution for off-label drug marketing.

The FDA’s Deputy Chief of Litigation, Eric Blumberg, said, “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion. It’s clear we’re not getting the job done with large, monetary settlements.”

Although the lawyer didn’t specify when the agency will start to implement sanctions, he warned company executives not to wait until the first charges are brought.

If you’re a corporate executive or are advising a corporate executive, now is the time to comply,” continued Blumberg.

Non-compliance with the order could result in executives incurring fines of up to $100,000 and up to one year in jail. In addition, regulators could also bar individuals from working in the drug industry.

Prosecuting executives for violations of the federal Food, Drug and Cosmetic Act falls under the Park Doctrine, a long forgotten, and rarely used statute named after the 1975 U.S. Supreme Court case against a retail food chain president.   In essence, the Park Doctrine allows prosecutors to hold CEOs responsible for the crimes of their underlings, even if they had no specific knowledge of their actions, on the general principle that CEOs have a responsibility to ensure that their organizations follow the law.

For small companies with rigorous compliance in place this should not be a problem, but for the giant pharma entities with upwards of 100,000 employees is it realistic, let alone possible, for the CEO to make sure they’re all obeying the law?

If you’re a CEO of a pharma company, or an employee who would like to stay employed, then look no further than SRxA.  We are here to help you through the complexities or compliance and create worry-free marketing and educational initiatives, guaranteed to help you and your boss sleep at night.

Contact us today for further information.